FDA.reportPublic FDA data

pramipexole dihydrochloride

Product NDC
29300-211
11-digit product format
293000211
Labeler code
29300
Product ID
29300-211_2ab8bb44-e4ba-4ae0-8ce9-0e9153de59f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pramipexole dihydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Unichem Pharmaceuticals (USA), Inc.
Application
ANDA207011
Marketing category
ANDA
Marketing start
2019-03-01
Substance
PRAMIPEXOLE DIHYDROCHLORIDE
Active strength
1.5 mg/1
Pharmacologic classes
Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207011-001PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE0.125MGTABLET / ORAL2018-12-19
A207011-002PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORAL2018-12-19
A207011-003PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORAL2018-12-19
A207011-004PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET / ORAL2018-12-19
A207011-005PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE1MGTABLET / ORAL2018-12-19
A207011-006PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET / ORAL2018-12-19

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 7 · 252 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A207011-001PRAMIPEXOLE DIHYDROCHLORIDE0.125MGTABLET / ORAL2018-12-19caaa826d4ba7…
2026-08-18 06:07:402026-07A207011-002PRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORAL2018-12-19caaa826d4ba7…
2026-08-18 06:07:402026-07A207011-003PRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORAL2018-12-19caaa826d4ba7…
2026-08-18 06:07:402026-07A207011-004PRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET / ORAL2018-12-19caaa826d4ba7…
2026-08-18 06:07:402026-07A207011-005PRAMIPEXOLE DIHYDROCHLORIDE1MGTABLET / ORAL2018-12-19caaa826d4ba7…
2026-08-18 06:07:402026-07A207011-006PRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET / ORAL2018-12-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207011-001PRAMIPEXOLE DIHYDROCHLORIDE0.125MGTABLET / ORAL2018-12-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207011-002PRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORAL2018-12-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207011-003PRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORAL2018-12-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207011-004PRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET / ORAL2018-12-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207011-005PRAMIPEXOLE DIHYDROCHLORIDE1MGTABLET / ORAL2018-12-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207011-006PRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET / ORAL2018-12-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207011-001PRAMIPEXOLE DIHYDROCHLORIDE0.125MGTABLET / ORAL2018-12-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207011-002PRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORAL2018-12-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207011-003PRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORAL2018-12-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207011-004PRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET / ORAL2018-12-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207011-005PRAMIPEXOLE DIHYDROCHLORIDE1MGTABLET / ORAL2018-12-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207011-006PRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET / ORAL2018-12-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A207011-001PRAMIPEXOLE DIHYDROCHLORIDE0.125MGTABLET / ORAL2018-12-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207011-002PRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORAL2018-12-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207011-003PRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORAL2018-12-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207011-004PRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET / ORAL2018-12-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207011-005PRAMIPEXOLE DIHYDROCHLORIDE1MGTABLET / ORAL2018-12-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207011-006PRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET / ORAL2018-12-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207011-001PRAMIPEXOLE DIHYDROCHLORIDE0.125MGTABLET / ORAL2018-12-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207011-002PRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORAL2018-12-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207011-003PRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORAL2018-12-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207011-004PRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET / ORAL2018-12-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207011-005PRAMIPEXOLE DIHYDROCHLORIDE1MGTABLET / ORAL2018-12-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207011-006PRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET / ORAL2018-12-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207011-001PRAMIPEXOLE DIHYDROCHLORIDE0.125MGTABLET / ORAL2018-12-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207011-002PRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORAL2018-12-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207011-003PRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORAL2018-12-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207011-004PRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET / ORAL2018-12-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207011-005PRAMIPEXOLE DIHYDROCHLORIDE1MGTABLET / ORAL2018-12-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207011-006PRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET / ORAL2018-12-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207011-001PRAMIPEXOLE DIHYDROCHLORIDE0.125MGTABLET / ORAL2018-12-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207011-002PRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORAL2018-12-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207011-003PRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORAL2018-12-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207011-004PRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET / ORAL2018-12-1903ed91905a0d…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A207011-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A207011-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A207011-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A207011-004AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A207011-005AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A207011-006AB174a2ff9319b5…
2020-11-12 02:37 UTC2020-11A207011-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A207011-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A207011-003AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A207011-004AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A207011-005AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A207011-006AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207011-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A207011-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A207011-003AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A207011-004AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A207011-005AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A207011-006AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A207011-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A207011-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A207011-003AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A207011-004AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A207011-005AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A207011-006AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A207011-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A207011-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A207011-003AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A207011-004AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A207011-005AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A207011-006AB1ea99ee380514…

Additional Listing Data#

Finished product
Yes
Brand name base
pramipexole dihydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAMIPEXOLE DIHYDROCHLORIDE1.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3D867NP06JInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
858625Internal RxNorm lookup
859033Internal RxNorm lookup
859040Internal RxNorm lookup
859044Internal RxNorm lookup
859048Internal RxNorm lookup
859052Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b978aa75-c62d-444b-9ec6-6c0d21a66688Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a67b8488-0225-64b1-be81-5cbe60d285a5Product name920221116
3863aae0-7028-3427-389e-3f6c8692e587Product name320190117

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
29300-211-10pramipexole dihydrochloride1000 in 1 BOTTLE, PLASTICTABLET100012
29300-211-19pramipexole dihydrochloride90 in 1 BOTTLE, PLASTICTABLET9012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29300-211PRAMIPEXOLE DIHYDROCHLORIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]11Current NDC, Legacy NDC, 2 package rows20240217_b978aa75-c62d-444b-9ec6-6c0d21a66688.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
pramipexole dihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEUnichem Pharmaceuticals (USA), Inc.b978aa75-c62d-444b-9ec6-6c0d21a666882025-10-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207011
application number: ANDA207011
ndc (product): 29300-211

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859033pramipexole dihydrochloride 0.125 MG Oral TabletPSNb978aa75-c62d-444b-9ec6-6c0d21a6668812
859040pramipexole dihydrochloride 0.25 MG Oral TabletPSNb978aa75-c62d-444b-9ec6-6c0d21a6668812
859044pramipexole dihydrochloride 0.5 MG Oral TabletPSNb978aa75-c62d-444b-9ec6-6c0d21a6668812
858625pramipexole dihydrochloride 0.75 MG Oral TabletPSNb978aa75-c62d-444b-9ec6-6c0d21a6668812
859052pramipexole dihydrochloride 1 MG Oral TabletPSNb978aa75-c62d-444b-9ec6-6c0d21a6668812
859048pramipexole dihydrochloride 1.5 MG Oral TabletPSNb978aa75-c62d-444b-9ec6-6c0d21a6668812
859033pramipexole dihydrochloride 0.125 MG Oral TabletSCDb978aa75-c62d-444b-9ec6-6c0d21a6668812
859040pramipexole dihydrochloride 0.25 MG Oral TabletSCDb978aa75-c62d-444b-9ec6-6c0d21a6668812
859044pramipexole dihydrochloride 0.5 MG Oral TabletSCDb978aa75-c62d-444b-9ec6-6c0d21a6668812
858625pramipexole dihydrochloride 0.75 MG Oral TabletSCDb978aa75-c62d-444b-9ec6-6c0d21a6668812
859052pramipexole dihydrochloride 1 MG Oral TabletSCDb978aa75-c62d-444b-9ec6-6c0d21a6668812
859048pramipexole dihydrochloride 1.5 MG Oral TabletSCDb978aa75-c62d-444b-9ec6-6c0d21a6668812
859033pramipexole dihydrochloride 0.125 MG (pramipexole 0.088 MG) Oral TabletSYb978aa75-c62d-444b-9ec6-6c0d21a6668812
859040pramipexole dihydrochloride 0.25 MG (pramipexole 0.18 MG) Oral TabletSYb978aa75-c62d-444b-9ec6-6c0d21a6668812
859044pramipexole dihydrochloride 0.5 MG (pramipexole 0.35 MG) Oral TabletSYb978aa75-c62d-444b-9ec6-6c0d21a6668812
858625pramipexole dihydrochloride 0.75 MG (pramipexole 0.525 MG) Oral TabletSYb978aa75-c62d-444b-9ec6-6c0d21a6668812
859052pramipexole dihydrochloride 1 MG (pramipexole 0.7 MG) Oral TabletSYb978aa75-c62d-444b-9ec6-6c0d21a6668812
859048pramipexole dihydrochloride 1.5 MG (equivalent to pramipexole 1 MG) Oral TabletSYb978aa75-c62d-444b-9ec6-6c0d21a6668812

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
29300-211-10293000211101000 TABLET in 1 BOTTLE, PLASTIC (29300-211-10) 1000 tablet2019-03-010000-00-00NoNoCurrent
29300-211-192930002111990 TABLET in 1 BOTTLE, PLASTIC (29300-211-19) 90 tablet2019-03-010000-00-00NoNoCurrent